US6663889B1 - Ambroxol-containing lozenge - Google Patents
Ambroxol-containing lozenge Download PDFInfo
- Publication number
- US6663889B1 US6663889B1 US10/031,580 US3158002A US6663889B1 US 6663889 B1 US6663889 B1 US 6663889B1 US 3158002 A US3158002 A US 3158002A US 6663889 B1 US6663889 B1 US 6663889B1
- Authority
- US
- United States
- Prior art keywords
- tablet
- sucking
- range
- sucking according
- ambroxol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime, expires
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/10—Expectorants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
Definitions
- the present invention relates to a new tablet for sucking containing the active substance ambroxol and having improved properties.
- the aim of the present invention is to make ambroxol into a pharmaceutical form which acts locally in the pharyngeal cavity in the form of a tablet for sucking.
- a suckable tablet of this kind to gain acceptance by the patient, apart from the efficacy the sensory impression is crucial.
- Another important point is the safety of the drug, i.e. steps must be taken to ensure that the intended quantity of active substance can be administered to the patient without any undesirable by-products or breakdown products which may arise after lengthy storage of the preparation.
- Breakdown products of this kind may be formed for various reasons, e.g. as a result of the thermal instability of the active substances or as a result of interactions, e.g. breakdown reactions which the active substance enters into with the pharmaceutical excipients or the packaging materials or which are catalysed by these materials.
- sugar alcohols are meant a group of monosaccharides which are obtained by reducing the carbonyl function.
- Polyhydroxy compounds of this kind which are not sugars but still taste sweet are commonly used as sugar substitutes.
- These generally crystalline water-soluble polyols are differentiated according to the number of hydroxy groups contained in the molecule, into tetritols, pentitols, hexitols etc.
- sugar alcohols examples include glycerol, threitol and erythritol, adonitol (ribitol), arabitol (formerly lyxitol) and xylitol, dulcitol (galactitol), mannitol and sorbitol (glucitol or sorbitol) [Cf. Römpp, Lexikon Chemie, Georg Thieme Verlag Stuttgart/New York 1998; Belitz-Grosch (3.), p. 701; Karrer, No. 139-158, 5401-5410; Kirk-Othmer 1, 569-588; (3.) 1, 754-777].
- systems of this kind should expediently contain excipients which make these tablets industrially easier to handle.
- release agents or lubricants are added to tablets of this kind.
- metal soaps such as calcium or magnesium stearate or calcium arachinate are conventionally used [U. I. Leinonen, H. U. Jalonen, P. A. Vihervaara, E. S. U. Laine: Physical and Lubrication Properties of Magnesium Stearate, Journal of Pharmaceutical Sciences 81 (1992) 1194-1197].
- sucrose which is also known from the prior art as a matrix material
- tablets of sufficient hardness can only be produced by using high compressive forces. Furthermore, this excipient causes caries.
- a tablet for sucking containing ambroxol based on sugar alcohols, particularly sorbitol, as matrix material can be obtained using a polyethyleneglycol and a pharmaceutically acceptable laminar silicate—particularly talc—as lubricant or release agent, in which the formation of a by-product cannot be detected, or is below the detection limits, even after lengthy storage.
- the polyethyleneglycols which may be used according to the invention expediently have a molecular weight in the range from 3,500 to 20,000.
- a polyethyleneglycol with a molecular weight in the range from 4,000 to 12,000 is preferred, while a polyethyleneglycol with a molecular weight of about 6,000 is particularly preferred.
- a polyethyleneglycol of this kind is known from the prior art under the name Macrogol 6000.
- the talc which is preferably used is generally a—common—hydrated magnesium silicate of the composition Mg 3 [(OH) 2 /Si 4 O 10 ] or 3 MgO 4 .SiO 2 .
- Mg 3 [(OH) 2 /Si 4 O 10 ] or 3 MgO 4 .SiO 2 is also possible to use another phyllosilicate which is acceptable from a pharmaceutical point of view.
- the amount of talc in a tablet for sucking according to the invention with a total mass of 1.5 g is in the range from 5 to 100 mg, preferably 20 to 80 mg, more preferably 30 to 60 mg and most preferably 60 mg.
- the amount of active substance in this case ambroxol—depends on the desired dosage and is also variable within a wide range.
- the proportion of active substance in a tablet for sucking is in the range from 1 to 50 mg, preferably 5 to 30 mg and most preferably in the range from 10 to 25 mg of ambroxol in the form of its hydrochloride.
- Composition A ambroxol HCl: 10.0 mg peppermint flavour: 16.0 mg saccharine - Na: 0.5 mg sorbitol: 1458.5 mg magnesium stearate: 15.0 mg total mass: 1500.0 mg Composition A is a comparative composition.
- Compositions A and C are prepared by conventional direct compressing technology.
- Composition B ambroxol HCl: 10.0 mg peppermint flavour: 16.0 mg saccharine - Na: 0.5 mg sorbitol: 1438.5 mg Macrogol 6000: 30.0 mg talc: 5.0 mg total mass: 1500.0 mg
- Composition B was produced by applying the talc only to the tablet surface using the compression chamber coating method [Gruber, Gläsel, Liske: Pre ⁇ talkbe Anlagenung, ein Beitrag zur Optimierung der Tablettenher too, Pharm Ind. 50 (1988) 839-845].
- Composition C ambroxol HCl: 20.0 mg peppermint flavour 16.0 mg saccharine - Na: 0.5 mg sorbitol: 1403.5 mg Macrogol 6000 30.0 mg talc 30.0 mg total mass: 1500.0 mg
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Nutrition Science (AREA)
- Inorganic Chemistry (AREA)
- Zoology (AREA)
- Physiology (AREA)
- Emergency Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pulmonology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Dry Formation Of Fiberboard And The Like (AREA)
- Saccharide Compounds (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Chemical And Physical Treatments For Wood And The Like (AREA)
- Fats And Perfumes (AREA)
- Treatments For Attaching Organic Compounds To Fibrous Goods (AREA)
- Jellies, Jams, And Syrups (AREA)
- Confectionery (AREA)
- Cosmetics (AREA)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19933148A DE19933148A1 (de) | 1999-07-20 | 1999-07-20 | Ambroxolhaltige Lutschtablette |
DE19933148 | 1999-07-20 | ||
PCT/EP2000/006437 WO2001005378A1 (de) | 1999-07-20 | 2000-07-07 | Ambroxolhaltige lutschtablette |
Publications (1)
Publication Number | Publication Date |
---|---|
US6663889B1 true US6663889B1 (en) | 2003-12-16 |
Family
ID=7914872
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/031,580 Expired - Lifetime US6663889B1 (en) | 1999-07-20 | 2000-07-07 | Ambroxol-containing lozenge |
Country Status (33)
Country | Link |
---|---|
US (1) | US6663889B1 (de) |
EP (2) | EP1200070B1 (de) |
JP (1) | JP3776041B2 (de) |
KR (1) | KR100743846B1 (de) |
CN (1) | CN1164263C (de) |
AT (1) | ATE246493T1 (de) |
AU (1) | AU776906B2 (de) |
BG (1) | BG65503B1 (de) |
BR (1) | BRPI0012553B8 (de) |
CA (1) | CA2379314C (de) |
CZ (1) | CZ301981B6 (de) |
DE (2) | DE19933148A1 (de) |
DK (1) | DK1200070T3 (de) |
EA (1) | EA004044B1 (de) |
EE (1) | EE04797B1 (de) |
ES (1) | ES2173823T3 (de) |
HK (1) | HK1045946B (de) |
HR (1) | HRP20020050B1 (de) |
HU (1) | HU229040B1 (de) |
IL (2) | IL147261A0 (de) |
ME (1) | MEP36808A (de) |
MX (1) | MXPA02000546A (de) |
NO (1) | NO331306B1 (de) |
NZ (1) | NZ516987A (de) |
PL (1) | PL197175B1 (de) |
PT (1) | PT1200070E (de) |
RS (1) | RS50246B (de) |
SI (1) | SI1200070T1 (de) |
SK (1) | SK284290B6 (de) |
TR (1) | TR200200106T2 (de) |
UA (1) | UA73313C2 (de) |
WO (1) | WO2001005378A1 (de) |
ZA (1) | ZA200200384B (de) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20030166732A1 (en) * | 2002-02-27 | 2003-09-04 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Ambroxol for the treatment of painful conditions in the mouth and pharyngeal cavity |
US20050075403A1 (en) * | 2003-10-02 | 2005-04-07 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Ambroxol for the treatment of inflammation in the pharynx |
US20050266058A1 (en) * | 2004-05-03 | 2005-12-01 | Boehringer Ingelheim International Gmbh | Topical preparations containing ambroxol |
US20070298100A1 (en) * | 2004-04-23 | 2007-12-27 | Norgine Europe Bv | Compressed Pharmaceutical Compositions Comprising Peg and Electrolytes |
WO2013091897A1 (en) | 2011-12-22 | 2013-06-27 | Centogene Gmbh | Combination of a compound having the ability to rearrange a lysosomal enzyme and ambroxol and/or a derivative of ambroxol |
US10265280B2 (en) | 2016-11-14 | 2019-04-23 | Mingwu Wang | Formulations for the treatment of ocular surface diseases and related methods |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE10125883A1 (de) | 2001-05-28 | 2002-12-12 | Serumwerk Bernburg Ag | Arzneimittel enthaltend einen Effektor des Glutathionmetabolismus zusammen mit alpha-Liponsäure im Rahmen der Nierenersatztherapie |
DE10208313A1 (de) * | 2002-02-27 | 2003-09-11 | Boehringer Ingelheim Pharma | Ambroxol für die Behandlung von schmerzhaften Zuständen im Mund und Rachenraum |
ITMI20032463A1 (it) * | 2003-12-16 | 2005-06-17 | Advance Holdings Ltd | Soluzione acquosa concentrata a base di ambroxolo |
DE102005018561A1 (de) * | 2005-04-21 | 2006-11-02 | Giesecke & Devrient Gmbh | Verfahren zum Betreiben eines Systems mit einem tragbaren Datenträger und einem Endgerät |
DE102010009369A1 (de) | 2010-02-25 | 2011-08-25 | Boehringer Ingelheim International GmbH, 55218 | Kindergesicherte Verpackung für Ambroxolhaltige Lutschtabletten |
BR112013012815A2 (pt) | 2010-12-23 | 2016-09-13 | Lectio Pharmaentwicklungs Und Verwertungs Gmbh | solução aquosa de ambroxol |
MX2017014725A (es) * | 2017-11-16 | 2019-05-17 | Productos Farm S A De C V | Dropropizina en combinacion con ambroxol en la forma farmaceutica de jarabe y tabletas. |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3034975A1 (de) | 1980-09-17 | 1982-04-29 | Dr. Karl Thomae Gmbh, 7950 Biberach | Arzneimittelkombination zur behandlung infektioeser atemwegerkrankungen |
EP0138020A2 (de) | 1983-09-17 | 1985-04-24 | Dr. Karl Thomae GmbH | Antiadhäsive Prophylactica und Arzneimittel enthaltend ein sekretolytisch wirksames Benzylaminderivat |
EP0546846A1 (de) | 1991-12-11 | 1993-06-16 | Therapicon Srl | Arzneimittel mit gesteuerter Wirkstoffabgabe |
EP0687464A2 (de) | 1994-06-15 | 1995-12-20 | Allphamed Pharbil Pharma GmbH | Verfahren zur Herstellung von Brausetabletten und Brausetabletten |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE19648576C2 (de) * | 1996-11-23 | 1999-08-12 | Lohmann Therapie Syst Lts | Lutschtablette zur modifizierten Freisetzung von Wirkstoffen im Gastrointestinaltrakt |
-
1999
- 1999-07-20 DE DE19933148A patent/DE19933148A1/de not_active Withdrawn
-
2000
- 2000-07-07 UA UA2002021424A patent/UA73313C2/uk unknown
- 2000-07-07 ES ES00949281T patent/ES2173823T3/es not_active Expired - Lifetime
- 2000-07-07 BR BRPI0012553A patent/BRPI0012553B8/pt not_active IP Right Cessation
- 2000-07-07 CN CNB008105510A patent/CN1164263C/zh not_active Expired - Lifetime
- 2000-07-07 CZ CZ20014633A patent/CZ301981B6/cs not_active IP Right Cessation
- 2000-07-07 IL IL14726100A patent/IL147261A0/xx active IP Right Grant
- 2000-07-07 DE DE50003209T patent/DE50003209D1/de not_active Expired - Lifetime
- 2000-07-07 TR TR2002/00106T patent/TR200200106T2/xx unknown
- 2000-07-07 SK SK81-2002A patent/SK284290B6/sk unknown
- 2000-07-07 JP JP2001510435A patent/JP3776041B2/ja not_active Expired - Lifetime
- 2000-07-07 CA CA002379314A patent/CA2379314C/en not_active Expired - Lifetime
- 2000-07-07 PL PL352276A patent/PL197175B1/pl unknown
- 2000-07-07 EA EA200200091A patent/EA004044B1/ru not_active IP Right Cessation
- 2000-07-07 WO PCT/EP2000/006437 patent/WO2001005378A1/de active IP Right Grant
- 2000-07-07 PT PT00949281T patent/PT1200070E/pt unknown
- 2000-07-07 SI SI200030189T patent/SI1200070T1/xx unknown
- 2000-07-07 HU HU0202021A patent/HU229040B1/hu unknown
- 2000-07-07 EP EP00949281A patent/EP1200070B1/de not_active Expired - Lifetime
- 2000-07-07 KR KR1020027000701A patent/KR100743846B1/ko active IP Right Grant
- 2000-07-07 MX MXPA02000546A patent/MXPA02000546A/es active IP Right Grant
- 2000-07-07 DK DK00949281T patent/DK1200070T3/da active
- 2000-07-07 AT AT00949281T patent/ATE246493T1/de active
- 2000-07-07 US US10/031,580 patent/US6663889B1/en not_active Expired - Lifetime
- 2000-07-07 AU AU62699/00A patent/AU776906B2/en not_active Expired
- 2000-07-07 EP EP03013014A patent/EP1352646A3/de not_active Withdrawn
- 2000-07-07 NZ NZ516987A patent/NZ516987A/en not_active IP Right Cessation
- 2000-07-07 ME MEP-368/08A patent/MEP36808A/xx unknown
- 2000-07-07 EE EEP200200027A patent/EE04797B1/xx not_active IP Right Cessation
- 2000-07-07 RS YU3802A patent/RS50246B/sr unknown
-
2001
- 2001-12-23 IL IL147261A patent/IL147261A/en unknown
-
2002
- 2002-01-16 ZA ZA200200384A patent/ZA200200384B/en unknown
- 2002-01-17 BG BG106316A patent/BG65503B1/bg unknown
- 2002-01-18 NO NO20020274A patent/NO331306B1/no not_active IP Right Cessation
- 2002-01-18 HR HR20020050A patent/HRP20020050B1/xx not_active IP Right Cessation
- 2002-10-16 HK HK02107498.0A patent/HK1045946B/zh not_active IP Right Cessation
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3034975A1 (de) | 1980-09-17 | 1982-04-29 | Dr. Karl Thomae Gmbh, 7950 Biberach | Arzneimittelkombination zur behandlung infektioeser atemwegerkrankungen |
EP0138020A2 (de) | 1983-09-17 | 1985-04-24 | Dr. Karl Thomae GmbH | Antiadhäsive Prophylactica und Arzneimittel enthaltend ein sekretolytisch wirksames Benzylaminderivat |
EP0546846A1 (de) | 1991-12-11 | 1993-06-16 | Therapicon Srl | Arzneimittel mit gesteuerter Wirkstoffabgabe |
EP0687464A2 (de) | 1994-06-15 | 1995-12-20 | Allphamed Pharbil Pharma GmbH | Verfahren zur Herstellung von Brausetabletten und Brausetabletten |
US6066335A (en) * | 1994-06-15 | 2000-05-23 | Horst Machoczek | Method of producing effervescent tablets and effervescent tablet |
Non-Patent Citations (1)
Title |
---|
Gruber, et al; "Presskammerbeschichtung, ein Beitrag zur Optimierung der Tablettenherstellung"; Pharmazeutische Industrie, vol. 50, 1988, 839-845. |
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20030166732A1 (en) * | 2002-02-27 | 2003-09-04 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Ambroxol for the treatment of painful conditions in the mouth and pharyngeal cavity |
US20050256193A1 (en) * | 2002-02-27 | 2005-11-17 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Ambroxol for the treatment of painful conditions in the mouth and pharyngeal cavity |
US20070224267A1 (en) * | 2002-02-27 | 2007-09-27 | Uwe Pschorn | Ambroxol for the treatment of painful conditions in the mouth and pharyngeal cavity |
US20100330176A1 (en) * | 2002-02-27 | 2010-12-30 | Boehringer Ingelheim Pharma Gmbh And Co. Kg | Ambroxol for the treatment of painful conditions in the mouth and pharyngeal cavity |
US20050075403A1 (en) * | 2003-10-02 | 2005-04-07 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Ambroxol for the treatment of inflammation in the pharynx |
US20070298100A1 (en) * | 2004-04-23 | 2007-12-27 | Norgine Europe Bv | Compressed Pharmaceutical Compositions Comprising Peg and Electrolytes |
US20050266058A1 (en) * | 2004-05-03 | 2005-12-01 | Boehringer Ingelheim International Gmbh | Topical preparations containing ambroxol |
WO2013091897A1 (en) | 2011-12-22 | 2013-06-27 | Centogene Gmbh | Combination of a compound having the ability to rearrange a lysosomal enzyme and ambroxol and/or a derivative of ambroxol |
US10265280B2 (en) | 2016-11-14 | 2019-04-23 | Mingwu Wang | Formulations for the treatment of ocular surface diseases and related methods |
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Owner name: BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MAERZ, FRIEDER ULRICH;VON DER HEYDT, HOLGER HANS-HERMANN;SCHMITT, HORST;REEL/FRAME:012836/0680 Effective date: 20020307 |
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